近期，IVD行业的AI概念股表现强势。安必平、迪安、华大、三诺、万孚、润达、金域、塞力医疗等多家IVD企业股价大幅上涨。 这一轮强势表现离不开 ...

Basel Medical Group Ltd. is the first Singapore-based med-tech to price an IPO on the Nasdaq this year, aggregating gross proceeds of $8.82 million on its debut. The funds will be used to power future ...

The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s ...

Critically, the Final Rule ended FDA’s longstanding policy of not actively regulating LDTs pursuant to its enforcement discretion (although the agency has long maintained it can regulate LDTs in the ...